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Letter for Breast Pain

Here is our sample letter of medical necessity written for a woman who has chronic breast pain or back pain caused by the weight of her implants, but does not have capsular contracture (her breasts do not feel hard). If you would like our assistance in personalizing your letter, please take our short survey and we will email you soon.  Click Here to download this letter as a word document that you can edit.

[Date]

[Insurance company] Claims Department
Address Line 1
Address Line 2

RE: Letter of Medical Necessity for [patient name]
Group/policy number: [Number]
Date(s) of service: [Dates]
Diagnosis: [Code & Description]

Dear [Insurance company] Claims Department:

I am writing on behalf of my patient, [patient name], to document medical necessity for explantation of two breast implants. [Patient name] has reported chronic breast pain. [Patient name] requires an explantation with permanent removal of both implants. On behalf of the patient, I am requesting coverage for this procedure.

[Patient name] is a [age]-year-old female with chronic breast pain. [Patient name] has been in my care since [date]. As a result of her pain, my patient has experienced significant deficits in her daily functioning, including [not being able to reach above her head, etc]. She has previously tried [any pain medications, including Tylenol] to relieve her pain. The attached medical records document [patient name]’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for the recipient that is more conservative or less costly.

In addition to her chronic pain on a daily basis, undergoing mammography has become too painful and the results are too inaccurate. Breast implants can interfere with the accuracy of mammography because the implant can hide breast tumors so that they are not visible on the mammogram. Inaccuracy is exacerbated when the patient has breast pain, as [Patient name] does. The lack of accurate mammograms makes it difficult to diagnose breast cancer at an early stage when it can be treated more effectively and with less radical treatments. Removal of her breast implants will allow her future mammography screenings to be much less painful and much more accurate.

According to the medical policy of [insurance company], my patient’s breast implant removal should be covered since she has severe pain that has negatively impacted her daily functioning. Her severe breast pain keeps her from [lifting her arms above her head, getting dressed, sleep, add relevant tasks]. Surgical implant removal is the standard treatment for breast pain and capsular contracture, and is clinically appropriate for my patient’s illness. This surgery is not primarily for the convenience of the patient or provider.

The [insurance company] policy [policy number] states the following within the plan under the “[TITLE OF SECTION OF RELEVANT POLICY LANGUAGE]” section:

[RELEVANT POLICY LANGUAGE].”

[Patient name]’s severe breast pain meets the above-stated criteria for [breast implant removal/medical necessity]. Removal of her breast implants and scar tissue surrounding them will relieve her breast pain and improve her daily functioning. Based on the language above, this procedure should be considered medically necessary.

My patient is requesting coverage for the [surgery name and CPT code #s]. Medical documentation is included.

Based on this information, I ask that you offer coverage for [Patient name]’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at [phone and email contact information]. I look forward to hearing from you.

Sincerely,

[Dr. signature]
[Dr. name, title]
[Provider identification number]

Enclosures: (Attach as appropriate)
Clinic notes and lab reports

 

Letter for Capsular Contracture

Here is our sample letter of medical necessity written for a woman with hard or painful breasts caused by capsular contracture (classified as Baker III or IV). If you would like our assistance in personalizing your letter, please take our short survey and we will email you soon.  Click Here to download this letter as a word document you can edit.

[Date]

[Insurance company] Claims Department
Address Line 1
Address Line 2

RE: Letter of Medical Necessity for [patient name]
Group/policy number: [Number]
Date(s) of service: [Dates]
Diagnosis: [Code & Description]

Dear [Insurance company] Claims Department:

I am writing on behalf of my patient, [patient name], to document medical necessity for explantation of two breast implants. I have diagnosed [patient name] with [Baker III/IV] capsular contracture and severe breast pain. [Patient name] requires an explantation with permanent removal of both implants. On behalf of the patient, I am requesting coverage for this procedure.

[Patient name] is a [age]-year-old female with [Baker III/IV] capsular contracture and severe breast pain. [Patient name] has been in my care since [date]. As a result of her pain, my patient has experienced significant deficits in her daily functioning, including [not being able to reach above her head, etc.]. I diagnosed her with chronic pain resulting from her breast implants. She has previously tried [any pain medications, including Tylenol] to relieve her pain. The attached medical records document [patient name]’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for the recipient that is more conservative or less costly.

In addition to my patient’s chronic pain on a daily basis, undergoing mammography has become too painful and the results are too inaccurate. Breast implants can interfere with the accuracy of mammography because the implant can hide breast tumors so that they are not visible on the mammogram. Inaccuracy is exacerbated when the patient has severe capsular contracture, as [Patient name] does. The lack of accurate mammograms makes it difficult to diagnose breast cancer at an early stage when it can be treated more effectively and with less radical treatments. Removal of her breast implants will allow her future mammography screenings to be less painful and much more accurate.

According to the medical policy of [insurance company], my patient’s breast implant removal should be covered since she has severe capsular contracture and breast pain. Her significant breast pain prevents her from [lifting her arms above her head, getting dressed, add relevant tasks]. Surgical implant removal is the standard treatment for chronic breast pain and capsular contracture and clinically appropriate for my patient’s illness. This surgery is not primarily for the convenience of the patient or provider.

The [insurance company] policy [policy number] states the following within the plan under the “[TITLE OF SECTION OF RELEVANT POLICY LANGUAGE]” section:

RELEVANT POLICY LANGUAGE

[Patient name]’s [Baker III/IV] capsular contracture and breast pain meets the above-stated criteria for [breast implant removal/medical necessity]. Removal of both her breast implants and scar tissue surrounding is the standard treatment to relieve her severe breast pain, eliminate her capsular contracture, and improve her bodily functioning. Based on the language above, this procedure should be considered medically necessary.

My patient is requesting coverage for the [surgery name and CPT code #s]. Medical documentation is included.

Based on this information, I ask that you offer coverage for [Patient name]’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at [phone and email contact information]. I look forward to hearing from you.

Sincerely,

[Dr. signature]
[Dr. name, title]
[Provider identification number]

Enclosures: (Attach as appropriate)
Clinic notes and lab reports

Letter for Ruptured Silicone Gel Implants

Here is our sample letter of medical necessity written for a woman with at least one ruptured silicone gel breast implant. If you would like our assistance in personalizing your letter, please take our short survey and we will email you soon.  Click here to download this letter as a word document you can edit.

[Date]

[Insurance company] Claims Department
Address Line 1
Address Line 2

RE: Letter of Medical Necessity for [patient name]
Group/policy number: [Number]
Date(s) of service: [Dates]
Diagnosis: [Code & Description]

Dear [Insurance company] Claims Department:

I am writing on behalf of my patient, [patient name], to document medical necessity for explantation of two breast implants. [Patient name] has undergone [MRI/ultrasound/mammogram/a comprehensive clinical exam] and there is clear evidence that [her right/ her left/both her] silicone gel breast implant[s] [is/are] ruptured. [Patient name] requires an explantation with permanent removal of both implants and scar capsules. On behalf of the patient, I am requesting coverage for this procedure.

[Patient name] is a [age]-year-old female who has been in my care since [date]. [As a result of her ruptured implant[s], my patient has experienced [pain] as well as significant deficits in her daily functioning, including [not being able to reach above her head, etc.]. [She has previously tried [any pain medications, including Tylenol] to relieve her pain.] She is unable to safely undergo mammography to screen or diagnose breast cancer, because the pressure of the procedure would spread the leaking silicone throughout the breast area and surrounding tissue and potentially to her lymph nodes, and from there to organs such as the lungs and liver. In
addition, even without mammography the leaking silicone [has migrated/can migrate] to her lymph nodes and from there to other organs, and [has resulted/can result] in the formation of granulomas that resemble lumps caused by breast cancer tumors. The FDA and general expert consensus have recommended explantation for all patients with both extracapsular- and intracapsular-ruptured silicone gel breast implants.

The attached medical records document [patient name]’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for the recipient that is more conservative or less costly.

According to the medical policy of [insurance company], my patient’s breast implant removal should be covered since she has [a] ruptured silicone gel implant[s]. Surgical implant removal is the standard treatment for a ruptured silicone gel implant and clinically appropriate for my patient. This surgery is not primarily for the convenience of the patient or provider.

The [insurance company] policy [policy number] states the following within the plan under the “[TITLE OF SECTION OF RELEVANT POLICY LANGUAGE]” section:

[RELEVANT POLICY LANGUAGE]

[Patient name]’s ruptured silicone gel implant[s] meets the above-stated criteria for [breast implant removal/medical necessity]. Removal of both her breast implants and intact scar tissue surrounding them is needed to prevent silicone gel leakage during the explantation surgery. Based on the language above, this procedure should be considered medically necessary.

My patient is requesting coverage for the [surgery name and CPT code #s]. Medical documentation is included.

Based on this information, I ask that you offer coverage for [patient name]’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at [phone and email contact information]. I look forward to hearing from you.

Sincerely,

[Dr. signature]
[Dr. name, title]
[Provider identification number]

Enclosures: (Attach as appropriate)
Clinic notes and lab reports

Health Care Industry Spends $30 Billion a Year on Marketing

Liz Szabo, Kaiser Health News: January 8, 2019.


Spending on health care marketing nearly doubled from 1997 to 2016, soaring to at least $30 billion a year, according to a study published Tuesday in JAMA.

The FDA is Still Letting Doctors Implant Untested Devices into Our Bodies

Jeanne Lenzer and Shannon Brownlee, Washington Post: January 4, 2019.


Ten years ago, Kathleen Yaremchuk raced to the bedside of a patient inexplicably gasping for breath. Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, Yaremchuk performed an emergency tracheotomy on the woman, cutting a hole in her windpipe, inserting a breathing tube and saving her life. When Yaremchuk began getting more calls over the following months for mysterious cases of respiratory distress, she launched a study to figure out what was going on.

All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. The object, used to hold a protein that stimulates bone growth, was cleared for sale by the Food and Drug Administration in 2003 without clinical testing in humans. When Yaremchuk and her colleagues reviewed the records of all 260 patients implanted with the device at Henry Ford Hospital between 2004 and 2009, they found that a significant number developed airway obstruction, trouble swallowing and respiratory failure, in some cases leading to death.

The neck implant is just one of the products associated over the past decade with 1.7 million injuries and more than 80,000 deaths. A searing global investigation last year by the International Consortium of Investigative Journalists places much of the blame on significant failings in the FDA’s oversight. The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and hemorrhage; and defibrillators that repeatedly shock patients beyond human endurance. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad. No wonder many patient advocates cheered when the FDA announced in November that it planned to make “transformative” changes in the way more than 80 percent of medical devices are cleared for sale in the United States. Some 32 million Americans walk around with such products in their bodies.

But the promised transformation is mere window dressing. Two key loopholes still exist, allowing most products to be approved for sale without clinical trials in humans. Although the FDA insists that high-risk devices undergo “stringent” testing to win approval, few actually do. A recent study, for example, found that only 5 percent of the highest-risk implantable cardiac devices were subjected to clinical trials on par with the testing required for drug approval.

In 1976, when medical devices first came under the regulatory control of the FDA, the agency simply grandfathered in all devices that were already on the market. Under this provision, known as the 510(k) pathway, new artificial joints, cataract lens implants and thousands of other devices developed after 1976 can win approval for sale (or “clearance” in FDA parlance) if the product is shown to have “substantial equivalence” to a previously cleared “predicate” device.” Four out of five devices are cleared for sale this way. Of those, at least 95 percent were cleared without clinical studies, according to research by Diana Zuckerman and her colleagues at the National Center for Health Research.

For some devices, that makes sense. You don’t need a clinical trial to test a new tongue depressor or hospital stretcher. But the agency also lets higher-risk devices through based on predicate devices, some of which have been recalled for safety problems. A recent study by researchers at the University of Oxford discovered that 16 percent of surgical meshes cleared for sale in the United States between 2013 and 2015 were based on products previously removed from the market because of serious complications. When one of us asked the FDA how this could happen, officials answered that the agency doesn’t evaluate the performance of the predicate when clearing devices for sale, just that there is (or was) a predicate.

According to the FDA, the “most impactful” change it is considering is recommending (not mandating) that companies cite predicate devices no older than 10 years. Yet device-makers could still cite predicates that were themselves based on earlier devices that may date back well past 10 years, something the FDA acknowledged in an email to us, stating that “devices cleared under a 510(k), regardless of how long the predicate has been on the market, have met the 510(k) regulatory review standard.”

The second loophole is the supplement pathway, which applies to new versions of the highest-risk devices, such as artificial hips, deep brain stimulators and spine implants. This process allows manufacturers to inform the FDA that they want to market an updated version of a device with minor changes — once again, allowing them to circumvent clinical trials. Researchers at Harvard found that 99 percent (5,829 of 5,906) of implanted cardiac devices, such as pacemakers and defibrillators, were approved through the supplement pathway from 1979 to 2012.

The supplement pathway has led to a number of disasters, such as one involving Medtronic’s Sprint Fidelis defibrillators, which are implanted in the chest to shock the heart if it goes into a deadly rhythm known as ventricular fibrillation. The company told the FDA in 2003 that it had updated the device to use thinner electrical leads into the heart. But the new wires were prone to fracture, hitting some patients repeatedly with shocks when their hearts were fine, and not delivering shocks to others who needed them. Doctors put the Sprint Fidelis into Bridget Robb, a patient from Pennsylvania in her early 30s. It shocked her 31 times in a span of minutes in 2007. She said in congressional testimony that it felt like being shot in the chest by a cannon at close range.

By the time Medtronic recalled the defibrillator in 2007, about a quarter-million were in circulation worldwide. Individuals implanted with it live under a sword of Damocles: They risk electrocution and possible death if they leave the Sprint Fidelis alone — and they risk death if their heart stops and the product fails. If they choose to have it removed, they face a 12 to 16 percent rate of serious complications or death from the surgery, according to a study published in 2010 in the journal Circulation.

Cases like these have received widespread coverage in the press but have had virtually no effect on FDA policy. Even a damning 2011 report by the Institute of Medicine (requested by the FDA), which deemed the agency’s 501(k) pathway so flawed it should be thrown out, fell on deaf ears.

Part of the problem lies in whom the agency believes it serves. At a recent meeting in Utah, the FDA’s device director repeatedly referred to manufacturers as the agency’s “customers” and showed a slide proclaiming “90 percent customer satisfaction.” Another slide documented the agency’s shorter and shorter approval times over the past eight years. These might not be the priorities of patients and taxpayers if they knew how often devices go on to harm people.

The FDA has become a captive agency. In 2007, Congress passed the Medical Device User Fee Amendments (MDUFA), which requires manufacturers to pay for device approvals. (Similar legislation, the Prescription Drug User Fee Act, directs money from drug companies to the FDA.) By 2018, 35 percent of the FDA’s budget for regulating devices came directly from the companies that make them. Zuckerman says that to continue collecting user fees under the MDUFA, the agency has to meet “performance goals” for faster approvals — leaving less time to evaluate products before they go on the market. It’s an inherent conflict of interest exacerbated by the revolving door of directors and commissioners who come from industry to the FDA and then go back. Before being appointed by President Trump to head the agency, Scott Gottlieb was paid millions of dollars for consultancies, directorships and other ties with some 20 health-care companies. He is a vocal supporter of Trump’s deregulation drive, arguing in 2013 that “the FDA’s caution is hazardous to our health.”

This is not a new problem. Before Gottlieb, President Barack Obama appointed Margaret Hamburg, who was then a director of Henry Schein, a leading medical-device distributor, to head the FDA. And in 2005, President George W. Bush named Lester Crawford, who abruptly resigned after just two months and came under criminal investigation for making false statements to Congress concealing his ties to companies the FDA regulates.

The relationship between the agency and the device industry is so cozy that in 2015, Rob Califf, then the FDA commissioner, met secretly with the Advanced Medical Technology Association (AdvaMed), the industry trade organization, to help craft the 21st Century Cures Act, which lowered the bar of evidence needed to approve devices even further.

Last fall, the FDA and AdvaMed were aware of the planned release of the Implant Files, the report by the investigative journalists’ consortium. AdvaMed executives were so concerned that they held a meeting to discuss strategies for dealing with the anticipated stories, which made headlines around the world in November. The executives promised their member companies that they would “hit back and hit back hard.” One day after the first reports were published, the FDA issued its “transformative” changes to the 510(k) pathway.

If Americans want devices that are safe and effective, they’ll need a new kind of regulation. First, the FDA should recategorize any implanted device as a high-risk or Class III product, which would subject it to rigorous clinical trials. Data from these studies should be made publicly available, or the manufacturer would forfeit the right to sell its product. And implanted devices should be entered into registries that track outcomes; patients should be given access to a website where they can immediately report problems and receive updates.

Lawmakers should also revive the congressional Office of Technology Assessment, which the House of Representatives killed in 1995, during a fit of anti-regulation insanity inspired by Newt Gingrich’s Contract With America. The office provided an invaluable service by independently assessing evidence for a wide range of technologies.

Finally, the FDA commissioner should be a civil servant without financial conflicts, not a political appointee (a practice started under Richard Nixon).

To do all of this, the FDA needs to overcome the constant threat of losing funding if it goes against the wishes of the industry it is supposed to regulate. Congress should repeal the MDUFA (and the prescription-drug equivalent) and fully fund the agency. Until the FDA requires clinical testing of implanted devices, as it does for drug approval, we simply won’t have the evidence to prove that a device is safe or effective.

See the original article here.

Breast Implants: the Trouble is Under the Skin

Radio-Canada Info: November 29, 2018.


Thousands of Canadian women have had silicone breast implants of a new generation approved in 2006 by Health Canada. Apart from some known complications,
these implants were said to be safe for women’s health.

Yet, in recent years, hundreds of women have had their implants removed due to various problems. New studies have shown that silicone implants are associated with the development of autoimmune diseases and a rare form of cancer.
Breast Implant Illness is still controversial.

An inquiry conducted by Enquête, in collaboration with the International Consortium of Investigative Journalists, Radio-Canada, CBC and the Toronto Star, revealed that Health Canada approved the release of these implants without long-term studies and allowed manufacturers to not adequately report breast implant-related adverse events for years.

See published version here.

29-Year-Old Fitness Model Gets Breast Implants Removed after She Says the Silicone Gave Her Seven Years of ‘Brain Fog, Bald Spots and Rashes’

Mary Kekatos, Daily Mail: December 19, 2018.

A fitness blogger said she had her breast implants removed because the silicone was ‘poisoning’ her.

Sia Cooper, the 29-year-old behind the blog Diary of a Fit Mommy, revealed she got implants in October 2011 to boost her self-confidence after weight loss left her with small breasts.

However, over the next seven years, the Florida mother-of-two struggled with extreme fatigue, facial rashes, chest pain, brain fog and even hair loss.

post-explant, 2 weeks

After undergoing multiple blood tests, diagnostic tests and X-rays that came back negative, Cooper was convinced her symptoms were related to what described as  ‘breast implant illness’.

 

Breast Reconstruction Options after Mastectomy


Many breast surgeons and breast cancer patients believe that breast reconstruction is an important step in recovering physically and mentally from a mastectomy.  Research shows that women who undergo flap procedures (described below) have a better quality of life after reconstruction than women undergoing reconstruction with breast implants.1

However, not all women are able to undergo those procedures.  Unfortunately, many patients are not given complete information about the different options for breast reconstruction, including the risks and benefits of each.  In fact, a recent study showed that only 43% of mastectomy patients received the information and counseling necessary to make an informed decision regarding their reconstruction choice.2

The Women’s Health and Cancer Rights Act of 1998 is a law that requires that private insurance companies pay for breast reconstruction if they pay for mastectomies.  This includes reconstruction on the removed breast, modification of the other breast to create a symmetric appearance, and treatment of any complications that result from a mastectomy or reconstruction.  The forms of reconstruction covered may vary by state and insurance provider, so it is important that you call your insurance provider to see which options will be covered in your particular case.3

This article does not provide medical advice, but we provide information based on scientific research and from speaking to many experts in the field.  We recommend discussing your treatment options with a physician whom you trust.  As a patient, you have the right to seek more than one medical opinion.

Which Type of Breast Reconstruction is Best?

The decision of which reconstruction option to choose, if any, is a personal one.  To make an informed choice, however, patients need to meet with breast surgeons who are skilled at the different options.  Since most breast surgeons only know how to do reconstruction with breast implants, they don’t usually provide good information to their patients about the benefits of other options.

There are several studies which look at the long-term outcomes for each of the reconstruction options, and these can help patients to make a decision.

For example, a study published in 2018 analyzed over 2000 reconstruction patients and found that patients who undergo autologous breast reconstruction (“flap” procedures) are generally more satisfied in the long-term than women who choose reconstruction with breast implants.  After two years, patients who chose to get flap procedures reported having a better quality of life than patients who got breast implants.  Some of the areas in which the flap patients reported greater satisfaction include their psychosocial, physical, and sexual well-being.4

The researchers also found differences in surgery-related complications within the first 2 years after surgery.  Flap procedures have significantly higher rates of short-term surgery-related complications that occur immediately following surgery.  In contrast, breast implants have more surgery-related complications that occur weeks or months after the surgery is completed. 5 In addition, women are likely to need multiple surgeries to replace implants over their lifetime.6

A description of the options for reconstruction is below.

Reconstruction with Breast Implants

Breast implants are the most common form of breast reconstruction after mastectomy.  7 This is probably because breast implants are the easiest form of reconstruction and most plastic surgeons are not skilled enough to perform the other types of breast reconstruction discussed below.  There are silicone gel breast implants and saline breast implants on the market, and both options have a high complication rate for reconstruction patients.  You will probably be told that breast implants are not lifetime devices, but that’s an understatement.  Studies by researchers and by implant manufacturers have shown that after three years, most reconstruction patients will have at least one serious complication.8,9

Below are some of the most common complications of breast implants.

In addition, women who have breast implants, either for mastectomy or healthy breasts, are more likely to develop a type of lymphoma (cancer of the immune system) called ALCL.17

You can read more about risks and complications related to breast implants here and more about the different types of breast implants here.  Despite the risks, some women get implants because they are not good candidates for other types of breast reconstruction.  Women who are very thin or very physically active, have poor veins, or who may become pregnant in the near future may not be good candidates for other reconstruction options.

Reconstruction with Autologous Tissue Transfer (Flap Procedures)

Autologous tissue transfer (also known as a flap or flap procedure) refers to any procedure in which the body’s own tissue is used to reconstruct breasts.  Surgeons take fat and other tissue from another part of a woman’s body and move it to create breasts.  Sometimes, implants are used along with the tissue transfer to create larger breasts.  When implants are used with flap procedures, the risk for complications is higher than for either procedure alone.  For that reason, it makes sense to choose either flap reconstruction or implants but not both.

There are various types of autologous tissue transfer as described below.

Flap Reconstruction with Muscle and Fat

In this procedure, surgeons take muscle and fat from other areas of the body and move it to the breast area.  The most common form of this procedure is the TRAM flap, which uses muscle and fat from the abdomen.  While using stomach muscle is typical, surgeons can also take muscle from the inner thigh or buttocks.  Reconstruction methods using fat and muscle create a more natural looking reconstruction than those using only fat due to their added firmness.   Also, the larger amount of tissue used during muscle and fat reconstructions enables the surgeon to create larger breasts than those with fat only.  A drawback to this type of surgery is its complexity.  Veins and arteries must be reattached to the muscle and fat, so this surgery requires an experienced vascular surgeon.  Even with a good surgeon, this surgery isn’t 100% successful.  However, if it is successful, these reconstructed breasts can last a lifetime.   But, if muscle is removed from the abdomen, the women will not have as much strength there as they did before.18

Flap Reconstruction with Fat Only

Some reconstructions are performed using only fat.  The most common form of this is the DIEP flap, which takes skin, vessels, and fat from the abdomen but spares the muscles.  Surgeons can take tissue from most areas of the body that have a large fat supply.19 Reconstruction with only fat takes more time than other procedures because the tissue has to be harvested and removed from the body before the reconstruction can take place.20 To be a good candidate for this procedure, women need more body fat to create the breast.  This means that women with low body fat or poor vascularity may not be good candidates for this surgery.  The difficulty of this form of reconstruction are similar to those of reconstructions done with muscle and fat.  However, since no muscle is used, patients should not expect to permanently lose strength in any part of their body.21

Reconstruction with the Latissimus Dorsi

This surgery, commonly known as Lat flap, uses the latissimus dorsi muscle to reconstruct breasts.  The latissimus dorsi is a muscle of the upper back that extends around the side of the body. This procedure is more likely to fail than some other flap procedures, but less likely to have surgery-related complications or need reoperations within the first two years.22

Lat flap can be performed on women who do not have enough body fat for other forms of autologous reconstruction, and is frequently used with breast implants.  Some surgeons prefer it because the only visible scar will be from the mastectomy, and because the muscle can remain attached to its original blood source, which lowers the chance of the tissue dying after transfer.  However, since the latissimus dorsi is a large and important back muscle, the procedure can lead to serious difficulties moving, lifting, or performing strenuous exercise.  Patients who choose this option can also expect to get fatigued more easily.23

It’s Your Choice

As you can see from the research above, flap procedures are a very good choice for women who want a lifetime solution that avoids the complications typical of breast implants, and the possible risk of developing lymphoma.  However, fewer doctors perform flap procedures.  They are also longer and more complicated surgeries than reconstruction using breast implants.  For this reason, it is extremely important that women choosing a flap procedure go to a surgeon who is very experienced in autologous reconstruction.

When making a reconstruction decision, it is important for each woman to weigh the risks and benefits of each procedure with a doctor that is capable of these different options, so that she can make a decision that is right for her.

Patient Satisfaction After Breast Reconstruction with Implants Compared to Flap Procedures

Katherine B. Santosa et al., “Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction.” JAMA Surgery (2018) 153(10):891-899.

For many women, breast reconstruction can be an important step in recovering physically and mentally after a mastectomy.  However, research shows less than half of mastectomy patients received the information and counseling necessary to make an informed decision regarding their reconstruction choice.

A 2018 study by Katherine Santosa and her colleagues found that patients who undergo autologous breast reconstruction (also called “flap” procedures), are generally more satisfied in the long-term than women who choose reconstruction with breast implants.  The study included 2,013 patients, 74% of whom got breast implants and 26% of whom had autologous reconstruction. Autologous tissue transfer refers to any procedure in which the body’s own tissue is used to reconstruct breasts. Surgeons take fat and other tissue from another part of a woman’s body, usually the abdomen, and move it to create breasts.

The researchers surveyed women on their quality of life 90 days before their mastectomy, and at 1, 2, 3, and 4 years after reconstruction. The survey included questions on four topics: Patients’ satisfaction with their breasts, emotional and social well-being, sexual well-being, and physical well-being. In the satisfaction with breasts category, women were asked questions about their breasts appearance, their satisfaction with breasts and how bras fit, and how the breasts feel to the touch. To understand women’s emotional and social well-being, researchers asked questions about body image and a woman’s confidence in social settings. Women were also asked about their sexual well-being, including questions about feelings of sexual attractiveness, sexual confidence, and comfort level during sex. Lastly, researchers asked women about their physical well-being, including information about pain, tightness, and any physical difficulty with performing daily activities.

Patients who chose autologous reconstruction reported higher satisfaction with their breasts than those who got breast implants. The women who had autologous reconstruction also reported greater emotional and social well-being and sexual well-being compared to before reconstruction. In contrast, patients who got breast implants reported worsened sexual well-being compared to before reconstruction.

The information from this study can provide useful information to patients and their doctors about patients’ likely quality of life following breast reconstruction with autologous or “flap” procedures compared to breast implants.

Read the original article here.

 

FDA Recommends “Modernizing” Review of Devices in Wake of Global Investigation

Jeanne Lenzer, The British Medical Journal: November 27, 2018

The US Food and Drug Administration is making changes to how medical devices are cleared for sale after a scathing investigation into the industry.

The global investigation into the medical device industry by journalists from 36 countries, including The BMJ, BBC Panorama, and the Guardian and led by the International Consortium of Investigative Journalists, unearthed thousands of documents to reveal rising numbers of malfunctions and injuries.

Scott Gottlieb, FDA commissioner, and Jeff Shuren, director of the Center of Devices and Radiological Health, said in a statement that there would be changes to the 510(k) pathway that is used to clear four in every five devices for sale. The pathway approves devices not on the basis of testing in humans but on how similar devices are to previous devices, called “predicates,” some of which were approved decades ago.

Gottlieb and Shuren said that … they were “encouraging” manufacturers to “use more modern predicates,” [….]

However, the reform didn’t go far enough, said Diana Zuckerman, epidemiologist and president of the National Center for Health Research in Washington, DC. She told The BMJ that using more “modern” predicates says nothing about safety or effectiveness. She said that “newer doesn’t mean better” and that “since less than 5% of 510(k) devices undergo any type of clinical trials, there’s no assurance that any devices cleared through that pathway are safe or effective.”

In 1996 the US Supreme Court concluded that “since the 510(k) process is focused on equivalence, not safety . . . if the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”

A recent study found that 16% of mesh clearances were based on recalled devices. When the FDA was asked why it cleared mesh implants on the basis of predicate devices that had been withdrawn because of safety concerns, the agency said that it didn’t evaluate the performance of predicate devices when clearing devices for sale.

A study of high risk implanted cardiac devices found that only 5% underwent clinical testing that even partly approximated the testing required for drug approvals.

Nor is safety surveillance reliable. A Government Accountability Office analysis found that 99% of device related “adverse events” were never reported to the FDA and that the “more serious the event, the less likely it was to be reported.”

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